MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; Catheter, Biliary, Diagnostic

Model Number	M00558690
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was received by the customer on an unknown date.It was reported that the products were reported as damaged upon receipt by the customer.The patient was not present at the time of the event, and the product was not used in a procedure.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block e: this event was reported by the sales representative.The healthcare facility is: (b)(6).(b)(6).Phone number: +(b)(6).Fax number: (b)(6).Email: (b)(6).Block h6: imdrf device code a020504 captures the reportable event of tear, rip, hole in device packaging.

• Brand Name: CRE PRO
• Common Device Name: Catheter, Biliary, Diagnostic
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Cork Limited; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25851133
• Report Number: 3005099803-2026-02900
• Device Sequence Number: 14750855
• Product Code: FGE
• UDI-Device Identifier: 08714729797579
• UDI-Public: (01)08714729797579(17)280515(10)36535064
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558690
• Device Catalogue Number: M00558690
• Device Lot Number: 0036535064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 05/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown